Job Description : Responsibilities :
Responsibilities :
Identify and ensure implementation of opportunities to optimize / improve manufacturing processes including using engineering methods (e.
g., SIX Sigma and LEAN methods) employing technical design skills to re-design / design of and ensure equipment, tools, fixtures, etc are up to standards.
- Oversee the planning / preparation, execution, and documentation of engineering builds.
- Develop experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes and equipment;
analyze results, make recommendations, and develop reports.
- Analyze and resolve Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
- Support establishing project plans to ensure deliverables are completed to customer’s expectations.
- Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback;
and coordinate technician work.
Other incidental duties assigned by Leadership.
Qualifications and Skills :
- Strong verbal / written communication and interpersonal skills.
- Basic understanding of statistical techniques.
- Previous experience working with lab / industrial equipment or manufacturing support role.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Strong problem-solving, organizational, analytical, and critical thinking skills.
- Substantial understanding of processes and equipment used in assigned work.
- Ability to manage competing priorities in a fast-paced environment.
- Ability to work well independently as well as part of a team.
- Good leadership skills and ability to influence change.
- Ability to interact professionally with all organizational levels.
- Knowledge of and adherence to the client’s Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
- Knowledge of applicable FDA regulations for the medical device industry.
- Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence / control.
Education and Experience :
- Bachelor’s Degree in Engineering or Scientific field with 2 years of industry experience OR Master’s Degree in Engineering or Scientific field with 1 year of industry experience required.
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